Chemotherapy + Immunotherapy for Esophageal Cancer
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: M.D. Anderson Cancer Center
Must not be taking: Antibiotics, Immunosuppressants, Immunostimulants, others
Disqualifiers: Metastatic cancer, Squamous cell carcinoma, Uncontrolled diabetes, Active angina, others
No Placebo Group
Prior Safety Data
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?To learn if atezolizumab in combination with oxaliplatin and 5-fluorouracil (5-FU), when given before surgery, can help to control esophageal and/or gastroesophageal cancer. To learn if adding tiragolumab to the above drug combination can help to control the disease.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop taking your current medications. However, it does mention that patients should not have had prior chemotherapy or radiation therapy, and certain medications like systemic immunosuppressive agents should not be used close to the start of the trial. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the drugs Atezolizumab, Tecentriq, Fluorouracil, 5-Fluorouracil, 5-FU, Adrucil, Carac, Efudex, Fluoroplex, Oxaliplatin, Eloxatin for esophageal cancer?
Research shows that combinations including fluorouracil (5-FU) and oxaliplatin have been effective in treating advanced esophageal cancer, with studies indicating good response rates. Additionally, similar treatments using 5-FU with other drugs have shown promising results in esophageal cancer.
12345Is the combination of chemotherapy and immunotherapy generally safe for treating esophageal cancer?
The combination of chemotherapy drugs like 5-Fluorouracil (5-FU) and Oxaliplatin has been studied for safety in various cancer treatments, including esophageal cancer. In one study, 53% of patients experienced significant side effects, but these were considered manageable. Another study found that a combination of 5-FU and Oxaliplatin with other treatments was safe for esophageal cancer, suggesting a generally manageable safety profile.
678910How is the drug combination of Atezolizumab, Fluorouracil, and Oxaliplatin unique for esophageal cancer?
This treatment combines chemotherapy with immunotherapy, using Atezolizumab (an immune system booster) alongside Fluorouracil and Oxaliplatin (chemotherapy drugs), which is different from traditional chemotherapy alone. This combination aims to enhance the body's immune response against cancer cells while also directly targeting them with chemotherapy.
1381112Eligibility Criteria
This trial is for adults with localized esophageal or gastroesophageal adenocarcinoma who haven't had prior treatments. They must have certain blood and organ function levels, not be pregnant or breastfeeding, use contraception, and be medically fit for surgery. People with specific other health conditions or cancers are excluded.Inclusion Criteria
My white blood cell count is healthy without needing medication.
No supraclavicular, or para-aortic nodal enlargement unless biopsy negative
My hemoglobin level is at least 9 g/dL, possibly after a transfusion.
+20 more
Exclusion Criteria
My cancer is not classified as T1aN0, T4b, or M1.
I tested negative for HBsAg and positive for HBcAb.
I do not have uncontrolled diabetes, heart issues, high blood pressure, or mental health conditions that would prevent my participation.
+29 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Neoadjuvant Treatment
Participants receive Atezolizumab +/- Tiragolumab with Oxaliplatin and 5-Fluorouracil IV on Days 1 and 15 of each 28-day cycle for a total of 6 doses
12 weeks
6 visits (in-person)
Surgery
Participants undergo surgery to remove localized esophageal and gastroesophageal adenocarcinoma
1 week
1 visit (in-person)
Adjuvant Treatment
Participants receive Atezolizumab +/- Tiragolumab on Day 1 of each 21-day cycle
24-48 weeks
8-16 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
Up to 3 years
Participant Groups
The study tests if atezolizumab combined with chemotherapy (oxaliplatin and fluorouracil) before surgery can control cancer better than current methods. It also examines the addition of tiragolumab to this combination to see if it offers further benefits.
2Treatment groups
Experimental Treatment
Group I: Cohort 2- Atezolizumab plus and Tiragolumab with Oxaliplatin and 5-fluorouracil (5-FU)Experimental Treatment5 Interventions
The combination of Atezolizumab + Tiragolumab with Oxaliplatin and 5-Flourouracil IV on Days 1 and 15 of each 28-day cycle for total of 6 doses followed by surgery followed by Atezolizumab + Tiragolumab on Day 1 of each 21-day cycle for a total of 48 weeks.
Group II: Cohort 1-Atezolizumab combination with Oxaliplatin and 5-fluorouracil (5-FU)Experimental Treatment4 Interventions
The combination of Atezolizumab with Oxaliplatin and 5-Fluorouracil IV on Days 1 and 15 of each 28-day cycle for total of 6 doses followed by surgery followed by Atezolizumab on Day 1 of each 21-day cycle for total of 24 weeks
Atezolizumab is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Tecentriq for:
- Melanoma
- Hepatocellular carcinoma
- Small cell lung cancer
- Non-small cell lung cancer
- Urothelial carcinoma
🇪🇺 Approved in European Union as Tecentriq for:
- Melanoma
- Hepatocellular carcinoma
- Small cell lung cancer
- Non-small cell lung cancer
- Urothelial carcinoma
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
M D Anderson Cancer CenterHouston, TX
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Who Is Running the Clinical Trial?
M.D. Anderson Cancer CenterLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Interferon alfa-2a and fluorouracil in the treatment of patients with advanced esophageal cancer. [2018]The trial was undertaken to determine the response rate to and toxicities from the combination of interferon alfa-2a (IFN) and fluorouracil (FU) in patients with advanced esophageal cancer.
Phase II trial of oxaliplatin, leucovorin and fluorouracil in patients with advanced carcinoma of the esophagus. [2020]The aim of the study was to evaluate the efficacy and tolerability of the combination of oxaliplatin, fluorouracil and leucovorin in patients with advanced esophagus cancer.
Phase II trial of neoadjuvant cisplatin, 5-fluorouracil and interferon-alpha in operable squamous cell carcinoma of the esophagus. [2013]The combination of 5-fluorouracil (5-FU), cisplatin and interferon (IFN)-alpha was found to result in a high response rate in advanced esophageal squamous cell carcinoma (SCC).
Pembrolizumab versus paclitaxel for previously treated, advanced gastro-esophageal junction cancer: A systematic review and meta-analysis of randomized clinical trials. [2022]This paper aims to compare the effectiveness and safety of pembrolizumab and paclitaxel as a second line for patients with locally advanced gastroesophageal cancer.
Cetuximab plus cisplatin-5-fluorouracil versus cisplatin-5-fluorouracil alone in first-line metastatic squamous cell carcinoma of the esophagus: a randomized phase II study of the Arbeitsgemeinschaft Internistische Onkologie. [2022]This study assessed the activity of the mAb cetuximab in combination with cisplatin and 5-fluorouracil (5-FU) in advanced esophageal squamous cell carcinoma.
Phase I clinical and pharmacokinetic study of oral S-1 in patients with advanced solid tumors. [2022]To investigate the side effects, determine the maximum-tolerated dose (MTD), and study the pharmacokinetics of S-1, an oral fluoropyrimidine-based antineoplastic agent consisting of the fluorouracil (5-FU) prodrug tegafur combined with two modulators, 5-chloro-2,4-dihydroxypyridine and potassium oxonate.
A Phase II Study with Lead-In Safety Cohort of 5-Fluorouracil, Oxaliplatin, and Lapatinib in Combination with Radiation Therapy as Neoadjuvant Treatment for Patients with Localized HER2-Positive Esophagogastric Adenocarcinomas. [2018]Neoadjuvant 5-fluorouracil, oxaliplatin, and lapatinib in combination with radiation therapy is safe for neoadjuvant treatment for patients with localized human epidermal growth receptor 2-positive esophagogastric adenocarcinoma.Evaluation of this drug combination in a larger patient pool would allow for more accurate analysis of its efficacy.
First-line serplulimab or placebo plus chemotherapy in PD-L1-positive esophageal squamous cell carcinoma: a randomized, double-blind phase 3 trial. [2023]First-line systemic therapeutic options for advanced esophageal squamous cell carcinoma (ESCC) are limited. In this multicenter, double-blind phase 3 trial, a total of 551 patients with previously untreated, locally advanced or metastatic ESCC and PD-L1 combined positive score of ≥1 were randomized (2:1) to receive serplulimab (an anti-PD-1 antibody; 3 mg/kg) or placebo (on day 1), plus cisplatin (50 mg/m2) (on day 1) and continuous infusion of 5-fluorouracil (1,200 mg/m2) (on days 1 and 2), once every 2 weeks. The study met the primary endpoints. At the prespecified final analysis of progression-free survival (PFS) assessed by the blinded independent radiological review committee, serplulimab plus chemotherapy significantly improved PFS compared with placebo plus chemotherapy (median PFS of 5.8 months and 5.3 months, respectively; hazard ratio, 0.60; 95% confidence interval, 0.48-0.75; P < 0.0001). At the prespecified interim analysis of overall survival (OS), serplulimab plus chemotherapy also significantly prolonged OS compared with placebo plus chemotherapy (median OS of 15.3 months and 11.8 months, respectively; hazard ratio, 0.68; 95% confidence interval, 0.53-0.87; P = 0.0020). Grade 3 or higher treatment-related adverse events occurred in 201 (53%) and 81 (48%) patients in the serplulimab plus chemotherapy group and the placebo plus chemotherapy group, respectively. Serplulimab plus chemotherapy administered every 2 weeks significantly improved PFS and OS in patients with previously untreated, PD-L1-positive advanced ESCC, with a manageable safety profile. This study is registered with ClinicalTrials.gov ( NCT03958890 ).
A phase II study on continuous infusional paclitaxel and 5-Fu as first-line chemotherapy for patients with advanced esophageal cancer. [2022]This study was performed to evaluated the efficacy and safety of continuous infusional paclitaxel and 5-Fu as first-line chemotherapy in patients with advanced esophageal squamous cell cancer (ESCC).
A phase II and pharmacokinetic study of first line S-1 for advanced gastric cancer in Taiwan. [2022]To evaluate the efficacy, safety and pharmacokinetic profiles of S-1, which composed of tegafur (FT, a prodrug of 5-FU), 5-chloro-2,4-dihydroxypyridine and potassium oxonate (Oxo), in Taiwanese advanced gastric cancer (AGC) patients.
Nimotuzumab with cisplatin or fluorouracil on human esophageal squamous cell carcinoma EC1 cells. [2019]To investigate the effects of nimotuzumab (h-R3) with cisplatin (DDP) or fluorouracil (5-FU) on human esophageal squamous cell carcinoma (ESCC) EC1 cells.
Gene expression changes in a chemoresistant model with human esophageal cancer xenografts using cDNA microarray. [2015]5-Fluorouracil (5-FU) and cisplatin combined chemotherapy (FP) is commonly used for esophageal cancer. Acquired resistance needs to be overcome to improve the chemotherapeutic effect.